For several years, I noticed that a person or persons
unknown at Genentech, then later at
Roche, was reading my blog. I knew from
discussions with friends that the company had been debating the idea of getting
back into the antibiotics field but had always shied away – until this
year. In February, Roche dipped its feet
in the water with a deal
with RQx for the discovery of small molecule antibiotics active against Gram
negative pathogens. Around the same
time, I received a call from a headhunter looking for someone to head Roche’s
anti-infectives group. I asked, “What
anti-infectives group?” incredulously. They explained that they were looking
for a leader with clinical and scientific expertise in antivirals,
antibacterials and diagnostics where about 20% of the job would be in the
antibacterial realm. I responded that it
would not be me and that I didn’t know anyone who would fit that bill. But I
knew at that point that they had decided to try and get into antibacterial
discovery and development – but I don’t know if they managed to recruit anyone
for that position.
Today Roche and Polyphor announced a deal
for Polyphor’s anti-pseudomonas drug POL7080. Polyphor has been one of my clients for a
number of years and I am extremely happy for them and for the world that this
deal has gone through. Although the
upfront payment was just under $40 million, the deal terms could be as much as
$500 million given that all the milestones are attained. The drug has completed basic phase I studies
and is ready for phase II development. The development of an antibiotic that targets only a single
pathogen, even one like Pseudomonas
aeruginosa – one of the most feared killers of hospitalized patients – will
be challenging to the highest degree. The other challenge is the commercial
one. What price will Roche be able to attain for such an antibiotic assuming
that they can demonstrate that it is active in patients with highly resistant
Pseudomonas infections (see my blog
on this)? Therefore, this is a high-risk deal.
Given the risk, I see the deal terms as being more than reasonable.
The question remaining in my mind is the following. Can Roche do this? Are they up to this very
difficult regulatory, clinical, developmental and commercial challenge? My experience with companies like Roche,
where they have exited from the anti-infectives area years ago (for Roche that
would be 1999), everyone internally with the appropriate expertise to meet such
a challenge is long gone. These companies struggle for years to rebuild – and even
then there is the issue of corporate patience while the rebuilding struggles go
on. Will the corporation remain resolved to go through with their commitments
as they begin to understand the enormity of the difficulties ahead?
In this case – I am rooting for Roche! I know how difficult
this decision must have been for them. I also think that the regulatory
authorities must get some kudos (especially EMA but also FDA with its recent unmet
needs guidance). Without a
regulatory path forward, products like POL7080 could never see the light of
day. Next – we need to get to value based pricing. Without this – the commercial prospects for
POL7080 are nil and a failure based on a commercial bomb will kill antibiotic
discovery and development for even more decades to come.
But – all that said – Go Roche!
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